Randomized clinical trial comparing the efficacy and safety of treatment with the once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or the once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes inadequately controlled on metformin monotherapy.

AIM: To compare the efficacy and safety of the once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes (T2DM) and inadequate glycaemic control on metformin. MATERIALS AND METHODS: Patients with T2DM with a glycated haemoglobin (HbA1c) concentration ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/d) were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 322) or sitagliptin 100 mg once daily (n = 320). The primary analysis assessed whether omarigliptin was non-inferior to sitagliptin in reducing HbA1c at week 24, based on the criterion of having an upper bound of the 95% confidence interval (CI) about the difference less than the non-inferiority bound of 0.3%. RESULTS: The mean baseline HbA1c was 7.5% in both groups. After 24 weeks, the least squares (LS) mean change in HbA1c from baseline was -0.47% in the omarigliptin group and -0.43% in the sitagliptin group, with a between-group difference of -0.03% (95% CI -0.15, 0.08). This result met the prespecified criterion for declaring non-inferiority. The LS mean change from baseline in fasting plasma glucose and the percentage of patients with HbA1c <7.0% or <6.5% at week 24 were similar in the two treatment groups. There were no notable differences in adverse events and the incidence of symptomatic hypoglycaemia was low and similar in the groups. CONCLUSIONS: In patients with T2DM and inadequate glycaemic control on metformin, the addition of omarigliptin 25 mg once weekly or sitagliptin 100 mg once daily led to similar improvements in glycaemic control. Both agents were generally well tolerated with a low incidence of hypoglycaemia.

Serum S100A12 and Progression of Coronary Artery Calcification Over 4 Years in Hemodialysis Patients.

BACKGROUND/AIM: Vascular calcification is common and contributes to increased cardiovascular mortality in hemodialysis (HD) patients. In this prospective study, we aimed to investigate the associations of serum S100A12 in the presence of severe coronary artery calcification (CAC) and the progression of CAC in HD patients. METHODS: Sixty maintenance HD patients and 30 controls were enrolled. Serum S100A12 levels were measured using ELISA. CAC scores (CACs) were measured twice at a 4-year interval using multislice spiral CT. The HD patients were classified as rapid progressors or slow progressors according to the change in the CACs across these 2 measurements (x0394;CACs). RESULTS: The incidences of rapid progression of CAC in patients with baseline CACs ≤10, CACs >10 and CACs >400 were 12.5, 40.0 and 64.3%, respectively. Both baseline and 4-year serum S100A12 levels were significantly higher in the rapid progressors than in the slow progressors (medians of 45.6 vs. 30.2 ng/ml, p < 0.001 and 62.3 vs. 39.4 ng/ml, p = 0.002, respectively). The serum S100A12 levels were significantly correlated with baseline CACs (r = 0.466, p < 0.001), 4-year CACs (r = 0.440, p < 0.001) and x0394;CACs (r = 0.392, p < 0.001). Importantly, the x0394;CACs were significantly correlated with x0394;S100A12 levels (r = 0.396, p < 0.001). Logistic regression analysis revealed that the serum S100A12 level was as an independent determinant of the presence of severe CAC and that the increment in the serum S100A12 level was a factor that was significantly independently associated with the progression of CAC. CONCLUSIONS: Serum S100A12 levels were significantly associated with the presence of severe CAC, and the increment in serum S100A12 levels was an independent determinant of the progression of CAC.

Derivation and validation of a prediction score for acute kidney injury in patients hospitalized with acute heart failure in a Chinese cohort.

AIMS: Acute kidney injury (AKI) is a common complication among patients hospitalized for acute heart failure (AHF), and is associated with increased mortality. The goal of this study was to derive and validate a prediction score for AKI in AHF patients. METHODS: The hospital medical records of 1709 patients with AHF were reviewed. AKI was defined as an increase in serum creatinine (SCr) of ≥26.4 µmol/L or ≥50% within 48 h. A multivariate logistic regression analysis was undertaken to develop a new prediction score. The area under the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow goodness-of-fit statistic test were calculated to assess the discrimination and calibration of the prediction score, respectively. RESULTS: Acute kidney injury developed in 32.2% of patients with AHF. Factors independently associated with the risk of AKI included: ≥70 years of age, ≥3 previous hospital admissions for AHF, systolic blood pressure <90 mmHg, serum sodium <130 mmol/L, heart functional class IV, proteinuria, SCr ≥104 µmol/L and intravenous furosemide dose ≥80 mg/day. A prediction score for AKI was derived based on the ß coefficients of each risk factor. Patients with ≥8 points would be considered at high risk for development of AKI (55.1% incidence vs 18% in those with <8 points, P < 0.001). Both the derived and validated datasets showed adequate discrimination (area under ROC curve was 0.76 in both datasets) and calibration (Hosmer-Lemeshow statistic test, P = 0.98 and 0.13, respectively). CONCLUSION: The newly derived and validated clinical prediction score may effectively predict AKI in the patients hospitalized with AHF.